Humira(reg) (Adalimumab) Significantly Reduces Signs and Symptoms in Rheumatoid Arthritis Patients

New data about HUMIRA(reg) (adalimumab) from the largest anti-TNF clinical study ever conducted in Europe, the ReAct trial (Research in Active Rheumatoid Arthritis), reaffirms the drug's safety and efficacy seen in pivotal clinical trials. These results along with other key data about HUMIRA's sustained benefit beyond five years and ability to inhibit the progression of rheumatoid arthritis (RA) were presented this week at the European League Against Rheumatism (EULAR) annual congress in Berlin.


Results from the ReAct trial's first 2,000 patients treated with Abbott Laboratories' HUMIRA indicate:


-- Approximately one in four patients treated with HUMIRA 40 mg every other week, in addition to their existing therapies, achieved clinical remission within three months.



-- The safety profile of HUMIRA in this trial was consistent with the overall safety database from pivotal RA HUMIRA trials.



-- Forty-two percent of the patients responded favorably to HUMIRA within two weeks after the first dose.



-- HUMIRA proved effective in RA patients who had previous experience with other disease modifying anti-rheumatic drugs (DMARDs).


"The data on safety and efficacy from such a large trial confirm the favorable outcomes seen in the initial HUMIRA pivotal trials in RA," said G. R. Burmester, M.D., professor of medicine, Charite Humboldt University, Berlin, Germany.


ReAct Data Show HUMIRA Safe and Effective Treatment in Real-Life Setting


In this open-label study, patients with long-standing moderate to severe RA were treated with HUMIRA 40 mg every other week in addition to their existing therapies. The ReAct trial was considered a "real-life" study because patients met national treatment guidelines, meaning they represented different stages of the disease, as well as varying treatment experiences. The trial also explored the benefits of an "add-on" therapy, in this case HUMIRA, to the current standard of RA care, which is methotrexate. Finally, ReAct captured data from a broad patient population representing individuals from 11 European countries. Other trials may not be considered real-life because of restrictions in patient eligibility requirements, as well as patient population size and diversity.


Twenty-four percent of the ReAct patients achieved clinical remission, DAS28







The positive effect of HUMIRA was observed two weeks after the first dose was given, with 42 percent of patients achieving an ACR 20 response. ACR (American College of Rheumatology) 20, 50 and 70 criteria are used to define improvement. ACR 20 represents a 20 percent improvement in tender and swollen joint counts, plus a 20 percent improvement in three of five other key clinical measures.


Also after the first dose, 6 percent of patients achieved clinical remission in disease activity (DAS28 score of